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MDSAP cost per jurisdiction
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MDSAP cost per jurisdiction
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  Post Number #1  
Old 12th January 2018, 01:14 AM

Total Posts: 91
Question MDSAP cost per jurisdiction

Hello everyone,

How much does an MDSAP audit cost approximately? How much more does it cost for each additional jurisdiction to be audited? Say, a company wants to market in Canada, US, Japan and Australia. How much more does it cost to audit the 4 jurisdictions compared to just doing Canada and US?

If you could clarify, thank you.

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  Post Number #2  
Old 12th January 2018, 11:50 AM

Total Posts: 1,158
Re: MDSAP cost per jurisdiction

I've heard wildly varying costs. For a 10-person company, I've seen $30K and heard up to $50k. (I think the $30K was for all jurisdictions and don't know the details on the others). I think the only way to know is to get a quote from your registrar. They would be in the best position to tell you your expected cost.
  Post Number #3  
Old 12th January 2018, 03:58 PM

Total Posts: 199
Re: MDSAP cost per jurisdiction

I don't think there isn't that much difference in cost for each jurisdiction. The audit time calculation spreadsheets don't have any adjustments based on included jurisdictions, and all jurisdiction specific requirements seem to be already incorporated into each task. For example, there is an audit task for Device Marketing Authorization and Facility Registration, or Adverse Events and Advisory Notices, so whether you have 1, 2 or 5 countries, it does not change the audit time all that much.
Thank You to mihzago for your informative Post and/or Attachment!
  Post Number #4  
Old 22nd January 2018, 08:02 AM

Total Posts: 15
Re: MDSAP cost per jurisdiction

Has anyone in the UK had a quote from their NB?

Our NB have quoted approx. 12500, we are a small company with 60 employees. The way the letter was written was similar to when a builder sends a quote when they clearly don't want the job
  Post Number #5  
Old 24th January 2018, 12:39 PM

Total Posts: 58
Re: MDSAP cost per jurisdiction

Dear mihzago, you are incorrect in your statement. The calculation sheet on the FDA website requires you to include the amount of applicable regulations under MDA.
Guess what, the total amount of audit days increases.
And: the calculation is task based. Not head count based. Result: if you are to apply under MDSAP for only one regulation (for example Canada), you will be audited for about 6 days. If not more... Independent of whether you are 2 or 200 employees.
Heard several manufacturers indicate that they will drop their Canada licenses - result: Less medical devices available.
  Post Number #6  
Old 24th January 2018, 12:53 PM

Total Posts: 199
Re: MDSAP cost per jurisdiction

so, in your calculation, assuming the same number of tasks (which are dependent on the QMS processes), and the size of the company (there is time reduction for companies under 45 and 15 of 10% and 20% respectively), what is the difference in audit time if you include various jurisdictions?

You said 6 days with Canada only. How much more if you include other countries? Is there a difference in days?

Please read my statement again. I didn't say there is no difference, and I was pretty clear stating that the audit is based on tasks. My claim was that addition/removal of a jurisdiction is insignificant compared to the entire audit duration.

Some manufacturers may be dropping Canada, because so far only Canada requires MDSAP.
  Post Number #7  
Old 8th February 2018, 05:32 AM
Dave-h's Avatar

Total Posts: 58
Cool Re: MDSAP cost per jurisdiction

When including all of the costs associated with the audit (auditor travelling time, preparation time, report writing, annual admin fee etc), to have MDSAP for just Canada would cost around 23,000 per year. That is without the Health Canada registration costs.

We'll probably be dropping Canada. Too costly and too burdensome.
Thank You to Dave-h for your informative Post and/or Attachment!
  Post Number #8  
Old 16th May 2018, 10:55 AM

Total Posts: 2
Re: MDSAP cost per jurisdiction

Dear Nozzle,

Our NB quoted €30k on top of their several thousands for the ISO 13485:2016. And yearly 24k extra after that.
Which is your NB (BSI UK?)

Thanks, Maarten

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